Label: PAIN RELIEVING ROLL-ON GEL- menthol, 10% gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 19, 2020

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  • Pain Relieving Roll-On Gel

    Active ingredient Purpose

    Menthol 10%.............Cooling Pain Reliever

  • PURPOSE

    Uses: For the temporary relief of minor aches and pains of muscles and joints associated with:

    • backache • arthritis • strains • bruises • sprains

  • WARNINGS

    Warnings: For external use only

    Flammable: Keep away from excessive heat or open flame.

  • WHEN USING

    When using this product: Avoid contact with the eyes. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of product and consult a physician. Do not apply to wounds or damaged skin. Do not bandage tightly.

  • DO NOT USE

    Do not use in eyes. In case of contact, rinse thoroughly with water.

  • INSTRUCTIONS FOR USE

    Directions

    Adults and children 2 years of age and older: Apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a physician.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding: Ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately.

  • OTHER SAFETY INFORMATION

    Store in a cool dry place with lid closed tightly.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Organic Aloe Leaf Juice, Ethyl Alcohol, White Camphor Essential Oil, Meadowfoam Seed Oil, Cannabidiol (CBD)

    from Hemp Extract, Capsicum Fruit Oleoresin, Sweet Basil Leaf Oil, Black Pepper Oil, Roman Chamomile Flower Oil, German Chamomile Flower Oil, Cinnamon Leaf Oil, Citronella Oil, Eucalyptus Leaf Oil, Helichrysum Flower Oil, Ginger Root Oil, Pink Grapefruit Peel Oil, Juniper Berry Oil, Lemongrass Oil, Peppermint Oil, Pine Needle Oil, Ravensara Oil, Rosemary Leaf Oil, Spearmint Oil, Wild Oregano Oil, Glycerin, Witch Hazel Water, Organic Alcohol, Phenoxyethanol, Carbomer, Triethanolamine, Tetrasodium Glutamate Diacetate

  • QUESTIONS

    Questions or Comments? (877) 744-4779

  • DOSAGE & ADMINISTRATION

    Adults and children 2 years of age and older: Apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a physician.

  • INDICATIONS & USAGE

    Uses: For the temporary relief of minor aches and pains of muscles and joints associated with:

    • backache • arthritis • strains • bruises • sprains

  • Individual Unit Label

    NDC 73842-001-01 Roll On Bottle 89 mL

    Pain Relieving Roll-On Gel Label

    Pain Relieving Roll-On Gel 6-pack Label

    NDC 73842-001-02 Case of 6 bottles (Net Vol. 534 mL)

    Pain Relieving Roll-On Gel 6-pack Label

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVING ROLL-ON GEL 
    menthol, 10% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73842-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CINNAMON LEAF OIL (UNII: S92U8SQ71V)  
    CITRONELLA OIL (UNII: QYO8Q067D0)  
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
    ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV)  
    CAMPHOR OIL, WHITE (UNII: 26P3H26Z9X)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    CAPSICUM OLEORESIN (UNII: UW86K581WY)  
    BLACK PEPPER OIL (UNII: U17J84S19Z)  
    BASIL (UNII: 2U0KZP0FDW)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    HELICHRYSUM ITALICUM FLOWER OIL (UNII: O97ZV7726K)  
    GINGER OIL (UNII: SAS9Z1SVUK)  
    JUNIPER BERRY OIL (UNII: SZH16H44UY)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)  
    CRYPTOCARYA AGATHOPHYLLA LEAF OIL (UNII: XM00Z00H98)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    OREGANO LEAF OIL (UNII: 7D0CGR40U1)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CANNABIS SATIVA FLOWERING TOP (UNII: 8X454SZ22D)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    ALCOHOL (UNII: 3K9958V90M)  
    Product Characteristics
    Colororange (Light orange) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73842-001-0189 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/25/2020
    2NDC:73842-001-02534 mL in 1 CASE; Type 0: Not a Combination Product05/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/20/2020
    Labeler - Koi CBD LLC (072518336)
    Registrant - Brad Ridenour (072518336)
    Establishment
    NameAddressID/FEIBusiness Operations
    Koi CBD LLC072518336manufacture(73842-001)
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